Back to: Electronic Drug Registration and Listing (eDRLS) Using CDER Direct
Presenter
Matthew Lash, JD
Deputy Director, Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Matthew (Matt) Lash, J.D., serves as Deputy Director with the Center for Drug Evaluation and Research (CDER), Office of Compliance. In this role, Matt helps lead the Office’s talented team in its efforts to protect the public health through effective risk-based enforcement actions and the promotion of voluntary compliance.
Matt joined CDER in 2023 from the Department of Justice’s Consumer Protection Branch (CPB), where he served for 13 years as a trial attorney and Assistant Director. He represented the United States in criminal and civil cases implicating the Food, Drug, and Cosmetic Act (FDCA) and other statutes impacting consumers. As an Assistant Director, Matt supervised attorneys on many of CPB’s cases related to opioids, other prescription drugs, medical devices, and food products. He also represented CPB at stakeholder conferences, conducted training for attorneys and law enforcement professionals, and served on task forces related to important Department of Justice initiatives.
Before joining the government, Matt worked at a major law firm in Washington, D.C. Matt graduated cum laude from Georgetown University Law Center in 2006.
Abstract
This virtual conference keynote by the Deputy Director of CDER’s Office of Compliance emphasizes the critical importance of accurate drug registration and listing data (DRLS) to public health. The Office of Compliance’s broad mission includes protecting patients and consumers by overseeing the DRLS program, monitoring clinical trials, manufacturing, imports, recalls, and supply chain integrity, as well as combating counterfeit drugs and health fraud. Accurate DRLS data is essential for patient safety, enabling activities such as planning drug facility inspections, reviewing imported products to prevent harmful ones from entering the U.S., and tracking adverse event reports. This information also empowers consumers and healthcare providers with access to vital details through resources like DailyMed. Currently, over 148,000 drugs are listed with the FDA and more than 10,500 establishments are registered globally, highlighting the massive scale of this effort. The Office continuously works to improve data quality by issuing reminders, inactivating outdated entries, and addressing deficiencies. The FDA holds companies accountable for inaccurate or incomplete data, issuing warning letters and pursuing legal actions like the LGM case, where DRLS data helped lead to a permanent injunction against a company submitting false information. DRLS data is also integral to stopping dangerous conduct and addressing serious issues, such as those related to unapproved eye products or mole removers. The presentation also flags an important update: CDER Direct is now FDA Direct, which includes both drug and cosmetic product submissions following the Modernization of Cosmetics Registration Act of 2022, allowing firms to manage both types of submissions in one place. The ultimate goal remains voluntary compliance, with conferences like this serving as vital opportunities to communicate expectations and foster understanding.